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Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

NCT00831376 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-12

No results posted yet for this study

Summary

The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.

Conditions

Interventions

DRUG

levosalbutamol

Patients will be asked to take two puffs four times a day for 2 weeks

DRUG

racemic salbutamol

Patients will be asked to take two puffs four times a day for 2 weeks

DRUG

placebo

Patients will be asked to take two puffs four times a day for 2 weeks

Sponsors & Collaborators

  • University of Dundee

    lead OTHER

Principal Investigators

  • Karine L Clearie, MBBS, MRCP · Asthma and Allergy Research Group

  • Brian J Lipworth, MBchB · Asthma and Allergy Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00831376 on ClinicalTrials.gov